BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 17102341 · Received June 11, 2023

    Report

    Report Number
    3008352382-2023-00101
    Event Type
    Malfunction
    Date Received
    June 11, 2023
    Date of Event
    February 13, 2023
    Report Date
    July 18, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CATALOG: 442023, BATCH NO.:3031790 & 3011327. CUSTOMER REPORTED A POSITIVE ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT BASED ON OUR INTERNAL PROCEDURES AND THE INTENDED USE OF THE PRODUCT. RETENTION SAMPLES WERE VISUALLY INSPECTED, TESTED FOR VIABLE CONTAMINATION BY SUB-CULTURING ON TSA, CHOCOLATE, SABOURAUD AND SCHAEDLER AGARS PLATES, VOLTAGE OUTPUT AND GRAM STAIN. ALL RESULTS WERE SATISFACTORY. BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. CATALOG 442023, BATCH NO. UNKNOWN. CUSTOMER REPORTED A POSITIVE ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS NOT ABLE TO PERFORM AN INVESTIGATION TO THE RETENTION SAMPLES SINCE BATCH NUMBER IS UNKNOWN. A COMPLAINT HISTORY REVIEW CANNOT BE CONDUCTED RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE SINCE BATCH NUMBER IS UNKNOWN. THE BATCH HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN NONETHELESS BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR TO PRODUCT RELEASE.

    Description of Event or Problem · 0

    REPORT 3 OF 7. IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) GRAM STAIN REVEALED GRAM POSITIVE COCCI IN PAIRS AND CHAINS FROM AEROBIC BOTTLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GRAM STAIN REVEALED GRAM POSITIVE COCCI IN PAIRS AND CHAINS FROM AEROBIC BOTTLE. BCID WAS A DUAL POSITIVE FOR C. TROPICALIS AND STAPH SPP. C. TROPICALIS NOT REPORTED, NO TREATMENT CHANGE. CONFIRMATORY TESTING WAS CULTURE.

    Description of Event or Problem · 0

    REPORT 3 OF 7. IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) GRAM STAIN REVEALED GRAM POSITIVE COCCI IN PAIRS AND CHAINS FROM AEROBIC BOTTLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GRAM STAIN REVEALED GRAM POSITIVE COCCI IN PAIRS AND CHAINS FROM AEROBIC BOTTLE. BCID WAS A DUAL POSITIVE FOR C. TROPICALIS AND STAPH SPP. C. TROPICALIS NOT REPORTED, NO TREATMENT CHANGE CONFIRMATORY TESTING WAS CULTURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552249 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 UNKNOWN 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male